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Showing 1601–1620 of 29086 results

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Hylenex Injection (Mckesson) – Temperature Excursion (2024)

cGMP Deviations: Temperature excursion

Class IIModerate

FDASep 11, 2024Nationwide• Mckesson Medical-Surgical Inc. Corporate Office

Stewed Lotus Root (Lemonland) – Undeclared Allergens (2024)

Soybean Sauce is declared but Wheat and Fish (Anchovy) are not declared.

Class IIModerate

FDASep 11, 2024IN, WA• Lemonland Food Corp

Minute Maid Lemonade (Coca-Cola) – Mislabeled Product (2024)

Mislabeled. Cans of regular Minute Made Lemonade were placed in cartons labeled Minute Maid Zero Sugar Lemonade.

Class IIModerate

FDASep 10, 2024IN, KY, OH• COCA COLA Consolidated LLC

Bacalaitos Criollos Mix (Avole) – Undeclared Fish (2024)

Allergen not listed in the Contains statement: Fish

Class IIModerate

FDASep 9, 2024PR• Avole, Inc.

Sqwincher Electrolyte Mix (Kent Precision) – Metal Contamination (2024)

Potential foreign material (metal)

Class IIModerate

FDASep 9, 2024AL, ID, IL +8 more• Kent Precision Foods Group, Inc.

Sqwincher Electrolyte Mix (Kent Precision) – Metal Contamination (2024)

Potential foreign material (metal)

Class IIModerate

FDASep 9, 2024AL, ID, IL +8 more• Kent Precision Foods Group, Inc.

Electrolytes Flavor (Bevi) – Mislabeled Caffeine (2024)

Product is labeled as electrolytes but is actually caffeine

Class IIModerate

FDASep 6, 2024Nationwide• Hydration Labs Inc. dba Bevi

Pyridoxine HCL Injection (Empower) – Sterility Concern (2024)

Lack of Assurance of Sterility

Class IIModerate

FDASep 5, 2024Nationwide• Empower Pharmacy

Blue Tape Sriracha Sauce – Unlicensed Manufacturing (2024)

Acidified product was manufactured by firm without ODA license.

Class IIModerate

FDASep 3, 2024Nationwide• Blue Tape Sriracha

Mycophenolic Acid Tablets (Ascend) – Dissolution Failure (2024)

Failed Dissolution Specifications

Class IIModerate

FDASep 3, 2024Nationwide• Ascend Laboratories, LLC

Vivier Sheer SPF 30 (Vivier) – Microbial Contamination (2024)

Microbial Contamination of Non-Sterile Product

Class IIModerate

FDASep 3, 2024Nationwide• Vivier Pharma, Inc.

Chocolate Mini Waffle Cones (Hammond's) – Undeclared Milk (2024)

Undeclared Allergen

Undeclared allergen: milk

Class IIModerate

FDAAug 30, 2024Nationwide• Hammond's Candies Since 1920 II, LLC

Mupirocin Ointment (Glenmark) – Subpotent Drug (2024)

Subpotent Drug

Class IIModerate

FDAAug 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Asli Cinnamon Powder (Sands Impex) - Lead Contamination (2024)

Lead contamination

Class IIModerate

FDAAug 29, 2024IL, IN, MN +2 more• Sands Impex Inc. Dba Asli Fine Foods

Pickled Garlic (Niitakaya) – Undeclared Fish (2024)

Undeclared Allergen

Undeclared allergen (Fish) Ingredient

Class IIModerate

FDAAug 29, 2024AZ, CA, GA +5 more• Niitakaya USA Inc

Kara Boondhi (Grace Imports) - Undeclared Wheat (2024)

Undeclared Allergen

Undeclared wheat. The firm was notified by their supplier that they failed to include the allergen "wheat" on the label.

Class IIModerate

FDAAug 29, 2024GA, IN• Grace Imports, Inc

Pink Pickled Garlic (Niitakaya) – Undeclared Fish (2024)

Undeclared Allergen

Undeclared allergen (Fish) Ingredient

Class IIModerate

FDAAug 29, 2024AZ, CA, GA +5 more• Niitakaya USA Inc

Spicy Murukku Ingredients (Grace Imports) - Undeclared Wheat (2024)

Undeclared Allergen

Undeclared wheat. The firm was notified by their supplier that they failed to include the allergen "wheat" on the label.

Class IIModerate

FDAAug 29, 2024GA, IN• Grace Imports, Inc

Kerala Mixture (Grace Imports) - Undeclared Wheat (2024)

Undeclared Allergen

Undeclared wheat. The firm was notified by their supplier that they failed to include the allergen "wheat" on the label.

Class IIModerate

FDAAug 29, 2024GA, IN• Grace Imports, Inc

Barrier Therapy Skin Cream (PreQuel) – Microbial Contamination (2024)

Microbial contamination of non-sterile Products -

Class IIModerate

FDAAug 28, 2024Nationwide• PREQUEL SKIN

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